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Zoryve FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 9, 2023.

FDA Approved: Yes (First approved July 29, 2022)
Brand name: Zoryve
Generic name: roflumilast
Dosage form: Cream
Company: Arcutis Biotherapeutics, Inc.
Treatment for: Plaque Psoriasis

Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the topical treatment of plaque psoriasis.

  • Zoryve is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.
  • Zoryve contains roflumilast which is a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4). PDE4 is an intracellular enzyme that drives overactive immune responses in a range of inflammatory diseases including psoriasis, eczema, and COPD.
  • Roflumilast was first approved by the U.S. Food and Drug Administration (FDA) in 2011 as an oral formulation under the brand name Daliresp, which is used to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD).
  • Zoryve is approved for the treatment of mild, moderate, and severe plaque psoriasis with no limitations on duration of use.
  • Zoryve cream is applied to the affected areas once daily.
  • Common adverse reactions include diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections


Development timeline for Zoryve

Oct  6, 2023Approval FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11
Jul 29, 2022Approval FDA Approves Zoryve (roflumilast) Cream for the Treatment of Plaque Psoriasis
Dec 22, 2021FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis
Oct  4, 2021Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.